[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100629782":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":40,"centralContacts":51,"locations":60,"responsibleParty":93,"collaborators":96,"id":100,"slug":101,"hasResults":102,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":106,"eligibilityCriteria":107,"healthyVolunteers":102,"sex":108,"minAge":109,"maxAge":110,"enrollmentInfo":111,"targetDuration":114,"studyType":115,"phases":10,"briefSummary":116,"conditions":117,"keywords":122,"overallStatus":62,"whyStopped":10,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":138},{"fullName":5,"class":6},"Taichung Veterans General Hospital","OTHER",[8,14,19,23],{"label":9,"type":10,"description":11,"interventionNames":12},"Non-elderly, medication",null,"Patient with age \\\u003C 60 year-old, received standard dose DOAC or antiplatelet if protocol-defined DOAC ineligibility",[13],"Drug: Medication",{"label":15,"type":10,"description":16,"interventionNames":17},"Non-elderly, PFO closure","Patient with age \\\u003C 60 year-old, received PFO closure plus antiplatelet",[18],"Device: PFO closure",{"label":20,"type":10,"description":21,"interventionNames":22},"Elderly, medication","Patient with age ≥ 60 year-old, received standard dose DOAC or antiplatelet if protocol-defined DOAC ineligibility",[13],{"label":24,"type":10,"description":25,"interventionNames":26},"Elderly, PFO closure","Patient with age ≥ 60 year-old, received PFO closure plus antiplatelet",[18],[28,35],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"DEVICE","PFO closure","Transcatheter PFO closure by Amplatzer PFO occluder plus long-term antiplatelet (dual antiplatelet for at least 3 month and life-long single antiplatelet )",[24,15],[34],"closure",{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":10},"DRUG","Medication","Standard dose direct oral anticoagulant (DOAC) or Antiplatelet if protocol-defined DOAC ineligibility\n\n1. Unavoidable and non-substitutable severe drug interaction\n2. Newly onset on-label contraindication\n3. Patient refusal of DOAC",[20,9],[41,45,48],{"name":42,"affiliation":43,"role":44},"I-Hui Lee, MD, PhD","Taipei Veterans General Hospital, Taiwan","PRINCIPAL_INVESTIGATOR",{"name":46,"affiliation":5,"role":47},"Chi-Sheng Wang, MD","STUDY_DIRECTOR",{"name":49,"affiliation":50,"role":47},"Sung-Chun Tang, MD, PhD","National Taiwan University Hospital",[52,56],{"name":46,"role":53,"phone":54,"phoneExt":10,"email":55},"CONTACT","+886933375721","sam7227632@gmail.com",{"name":42,"role":53,"phone":57,"phoneExt":58,"email":59},"+886-4-23592525","3325","ihui_lee@hotmail.com",[61,76,86],{"facility":5,"status":62,"city":63,"state":10,"zip":64,"country":65,"countryCode":66,"cosmosGeoPoint":67,"geoPoint":72,"contacts":73},"RECRUITING","Taichung","40705","Taiwan","TW",{"type":68,"coordinates":69},"Point",[70,71],120.6839,24.1469,{"lat":71,"lon":70},[74],{"name":46,"role":53,"phone":75,"phoneExt":10,"email":55},"+886-933375721",{"facility":50,"status":62,"city":77,"state":10,"zip":78,"country":65,"countryCode":66,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"Taipei","100",{"type":68,"coordinates":80},[81,82],121.52639,25.05306,{"lat":82,"lon":81},[85],{"name":49,"role":53,"phone":10,"phoneExt":10,"email":10},{"facility":87,"status":62,"city":77,"state":10,"zip":78,"country":65,"countryCode":66,"cosmosGeoPoint":88,"geoPoint":90,"contacts":91},"Taipei Veterans General Hospital",{"type":68,"coordinates":89},[81,82],{"lat":82,"lon":81},[92],{"name":42,"role":53,"phone":10,"phoneExt":10,"email":59},{"type":44,"investigatorFullName":94,"investigatorTitle":95,"investigatorAffiliation":43,"oldNameTitle":10,"oldOrganization":10},"I-Hui Lee","Director, Attending Physician of Cerebralvascular department, Principal Investigator, Clinical Professor",[97,99],{"name":43,"class":98},"OTHER_GOV",{"name":50,"class":6},"100629782","senior-stroke-prevention-in-the-elderly-by-patent-foramen-ovale-closure-vs-anticoagulation-100629782",false,"NCT07479147","SENIOR: Stroke Prevention in the Elderly by Patent Foramen Ovale closuRe vs Anticoagulation","Patent Foramen Ovale-Related Stroke Management and Outcome: Age-dependent Risk Prediction and Atrial Cardiopathy Study (SENIOR Study)","SENIOR","Inclusion Criteria:\n\n* Patient or his\u002Fher legal representative signs a written informed consent\n* Participants who have diagnosed as PFO related stroke\n* For patient aged 18-59: patient with high risk PFO feature or RoPE score ≥ 7\n* For patient aged 60-90: patient with high risk PFO feature or RoPE score ≥ 4, must include cortical infarct\n\nExclusion Criteria:\n\n* Follow-up less than 6 months\n* Extracardiac right-to-left shunt\n* Known stroke mechanism was diagnosed","ALL","18 Years","90 Years",{"count":112,"type":113},400,"ESTIMATED","3 Years","OBSERVATIONAL","Patent foramen ovale (PFO) is an important mechanism of embolic stroke of undetermined source (ESUS). Current guidelines recommend PFO closure for high-risk PFO in patients younger than 60 years, and a recent retrospective cohort study from Taichung Veterans General Hospital has shown that closure is effective and safe in older adults; however, the optimal treatment strategy for those \\>60 years and direct head-to-head comparisons of PFO closure versus direct oral anticoagulants (DOACs) remain insufficient. Robust evidence from a multicenter study combining prospective and retrospective cohorts is warranted.\n\nThe SENIOR study is a multicenter observational cohort registry with a combined retrospective and prospective design. The prospective period is from September 15, 2025 to December 31, 2031, and the retrospective period covers January 1, 2013 to September 1, 2025; target sample sizes are 400 (prospective) and 500 (retrospective). We will enroll adults with ESUS and PFO; the prospective arm will focus on patients aged \\>60 years with PFO related stroke. Treatments will be assigned as PFO closure, standard-dose DOAC, or antiplatelet agents (if DOAC intolerance) by local principal investigator. The primary outcome is recurrent ischemic stroke or transient ischemic attack. Secondary outcomes include 6-month functional outcome, all stroke, and serial comparison of atrial cardiopathy changes. Safety endpoints include peri-procedural adverse events (including newly-onset atrial fibrillation), hemorrhagic stroke, and all caused mortality. Clinical presentation, imaging, cardiac testing, biomarker, and genetic data will be collected for stratified and multivariable analyses.",[118,119,120,121],"Ischemic Stroke","Embolic Stroke of Undetermined Source","Patent Foramen Ovale (PFO)","Elderly",[123,124,125,126,127,128],"patent foramen ovale","patent foramen ovale closure","embolic stroke of undetermined source","elderly","multi-center","anticoagulation","2026-03-18",{"date":131,"type":132},"2026-03-23","ACTUAL",{"date":134,"type":132},"2025-12-16",{"date":136,"type":113},"2031-12-31",{"name":5,"class":6},3]